Prednisone Tablet
FDA Recall NDC 0603-5337
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Prednisone (NDC 0603-5337). A significant event, classified as Class III, was initiated on Mar 04, 2020 by Endo Usa, Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Mar 04, 2020
Mar 25, 2020
13008 bottles
Recall Profile & Regulatory Data
Event ID
85136
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Par Pharmaceutical Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Apr 09, 2021
Product Description
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
Batch or Lot Expiration Information
Lot# : 8672518, Exp 12/21
Affected Packages Involved in this Recall
0603-5335-21Product
0603-5335-32Product
0603-5336-21Product
0603-5337-21Product
0603-5337-32Product
0603-5337-15Product
0603-5337-31Product
0603-5338-21Product
0603-5338-28Product
0603-5338-32Product
0603-5338-15Product
0603-5338-31Product
0603-5339-21Product
0603-5339-28Product
0603-5339-32Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
